U.S. patent application number 11/602810 was filed with the patent office on 2007-08-02 for method and composition for repair and reconstruction of intervertebral discs and other reconstructive surgery.
Invention is credited to James P. JR. Seaton, Linda Trebing.
Application Number | 20070179620 11/602810 |
Document ID | / |
Family ID | 38067883 |
Filed Date | 2007-08-02 |
United States Patent
Application |
20070179620 |
Kind Code |
A1 |
Seaton; James P. JR. ; et
al. |
August 2, 2007 |
Method and composition for repair and reconstruction of
intervertebral discs and other reconstructive surgery
Abstract
By providing an elastic form stable material which is capable of
being delivered directly to a specific desired location within a
living creature and providing increased strength and rigidity to
the injected location, disorders of the intervertebral disc of a
living creature are able to be effectively treated. Treatment of
defects or voids in soft tissue is achieved with a variation of the
subject material specific to each application. In the preferred
method, the elastic form stable material is injected directly into
the affected area, thereby achieving the desired result.
Inventors: |
Seaton; James P. JR.;
(Chatham, NJ) ; Trebing; Linda; (Madison,
NJ) |
Correspondence
Address: |
Melvin I. Stoltz
51 Cherry Street
Milford
CT
06460
US
|
Family ID: |
38067883 |
Appl. No.: |
11/602810 |
Filed: |
November 21, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60738857 |
Nov 22, 2005 |
|
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Current U.S.
Class: |
623/17.16 ;
623/17.12; 623/23.58 |
Current CPC
Class: |
A61F 2002/30583
20130101; A61L 27/18 20130101; A61L 2400/06 20130101; A61F 2/4611
20130101; A61F 2002/30014 20130101; A61F 2210/0061 20130101; A61F
2250/0018 20130101; A61L 27/18 20130101; A61F 2002/444 20130101;
A61F 2/442 20130101; A61F 2002/4627 20130101; A61F 2250/0098
20130101; A61F 2002/30075 20130101; A61F 2002/3008 20130101; A61F
2210/0085 20130101; A61F 2002/30069 20130101; C08L 83/04
20130101 |
Class at
Publication: |
623/017.16 ;
623/023.58; 623/017.12 |
International
Class: |
A61F 2/44 20060101
A61F002/44; A61F 2/28 20060101 A61F002/28 |
Claims
1. A method for treating a diseased or injured intervertebral disc
in a living creature, in particular a human being, comprising the
step of injecting a curable filler composition in said
intervertebral disc, wherein the curable filler material comprises
an elastic form stable material.
2. The method defined in claim 1, wherein said composition
comprises a curable elastomer-precursor composition.
3. The method defined in claim 2, wherein said composition
comprises a silicone elastomer.
4. The method defined in claim 3, wherein said silicone elastomer
comprises poly (dimethyl siloxane).
5. The method defined in claim 4, wherein said composition
additionally comprises a cross-linking agent and a diluent.
6. The method defined in claim 5, wherein said composition
comprises a radiopaque material.
7. The method defined in claim 6, wherein said radiopaque material
comprises one selected from the group consisting of silver powder,
barium sulfate, bismuth trioxide, zirconium dioxide, tantalum or
titanium powders or fibers, calcium sulfate, calcium phosphate,
hydroxyapetite, tri-calcium phosphate, and other medically
appropriate opacifier agents.
8. The method defined in claim 1, wherein the curable filler
material is further defined as comprising: A. between about 60% and
85% by weight based upon the weight of the entire composition of
poly (dimethyl siloxane); B. between about 2% and 5% by weight
based upon the weight of the entire composition of the
cross-linking agent; C. between about 100% and 20% by weight based
upon the weight of the entire composition of the diluent; and D.
between about 100% and 20% by weight based upon the weight of the
entire composition of the radiopaque material.
9. The method defined in claim 8, wherein said composition is
prepared in advance in a mixing-dispensing device.
10. The method defined in claim 8, wherein said composition is
delivered to the intervertebral disc by inserting a needle into the
internal cavity of the intervertebral disc and causing the filler
material to flow through the needle into the intervertebral
disc.
11. The method defined in claim 10, comprising the additional steps
of stopping the flow of the filler material when the intervertebral
disc has been filled with the filler material, and thereafter
withdrawing the needle from the intervertebral disc.
12. The method defined in claim 8, wherein the curable filler is
formulated to possess a durometer in the cured state which ranges
between about 10 A and 90 A.
13. The method defined in claim 8, wherein said filler material is
further defined as being flexible, when cured, to move, shift,
compress, and or elongate within the structure of the
intervertebral disc and the voids, cracks or weakened areas,
thereby providing varying actions or reactions.
14. The method defined in claim 5, wherein said composition
comprises bioactive compounds selected from the group consisting of
antibiotics, anti-microbial agents, tumor therapy compounds,
radioactive isomers, chemotherapy substances, local anesthetic
compounds steroid, and other medically appropriate bioactive
agents.
15. A method of preparing a composition for injection into a
disordered area of the body of a living creature, in particular a
human being, said composition comprising an elastic form stable
material consisting of a curable elastomer-precursor composition
and additives intermixed therewith and possesses substantially
reduced toxicity, thereby enabling its use prophylactically.
16. The method defined in claim 15, wherein the curable
elastomer-precursor composition comprises a silicone elastomer.
17. The method defined in claim 16, wherein said silicone elastomer
is poly (dimethoxy siloxane).
18. The method defined in claim 17, wherein the additives of said
composition comprises a cross-linking agent, a diluent, and a
radiopaque material.
19. The method defined in claim 18, wherein said composition is
packaged in a pre-assembled kit and the method further comprises
filling a first container with said silicone elastomer, and filling
a second container with said cross-linking agent.
20. The method defined in claim 19, wherein said kit comprises a
mixing-dispensing device incorporating said first and second
containers and a temporary seal between the first and second
containers, wherein one container is provided with a movable
stirrer.
21. The method defined in claim 20 wherein said mixing-dispensing
device comprises said containers and a mixing channel at the exits
of the two-containers, wherein said channel is provided with a
static mixing element.
22. The method defined in claim 18, comprising the steps of
thoroughly intermixing: A. between about 60% and 85% by weight
based upon the weight of the entire composition of poly (dimethyl
siloxane); B. between about 2% and 5% by weight based upon the
weight of the entire composition of the cross-linking agent; C.
between about 100% and 20% by weight based upon the weight of the
entire composition of the diluent; and D. between about 100% and
20% by weight based upon the weight of the entire composition of
the radiopaque material, thereby forming the desired inject
composition.
23. The method defined in claim 1, comprising the steps of
injecting the curable filler material in two or more stages.
24. The method defined in claim 23, in which the first stage is
directed to fill or repair cracks or voids in the annulus of the
intervertebral disc or to reinforce or strengthen a weakened or
herniated area of the annulus.
25. The method defined in claim 24, in which the durometer of the
resulting cured material is selected to provide increased strength
and stability to the disc annulus.
26. The method defined in claim 25, wherein the second stage
comprises filling the central portion of the intervertebral disc,
typically occupied by the nucleus pulposus in a healthy,
non-diseased intervertebral disc.
27. The method defined in claim 26, in which the durometer of the
resulting cured material injected in the second stage is selected
to provide increased flexibility, resilience, or a greater capacity
to distribute the forces seen by the intervertebral disc.
28. The method defined in claim 27, in which the durometer of the
resulting cured material injected in the second stage is different
from the durometer injected in the first stage.
29. The method defined in claim 26, in which a desired amount of
cured material injected in the first stage is removed to provide a
void within the repaired or augmented annulus.
30. The method defined in claim 29, in which the curable filler
composition is injected into the void created.
31. The method defined in claim 1, in which the injection of the
curable filler composition is applied in combination with a fibrous
or mesh structure, such that the fibrous or mesh structure serves
to contain the injectable filler composition within the
intervertebral disc.
32. The method defined in claim 1, in which the injection of the
curable filler composition is applied in combination with a disc
oblation procedure, such that a void is created within the
intervertebral disc for the curable filler material.
33. The method defined in claim 1, in which the injection of the
curable filler composition is applied in combination with a balloon
kyphoplasty procedure, or similar deployment of an expandable
device, such that a void is created within the intervertebral disc
for the curable filler material.
34. The method defined in claim 1, in which the injection of the
curable filler composition is applied in combination with
application of sutures or surgical closure devices, such that the
devices seal the periphery of the intervertebral disc and serves to
contain the injectable filler composition within the intervertebral
disc.
35. The method defined in claim 1, in which the injection of the
curable filler composition is applied in combination with
application of fibrin glue devices, such that the devices seal the
periphery of the intervertebral disc and serves to contain the
injectable filler composition within the intervertebral disc.
36. The method defined in claim 10, wherein said composition is
directionally delivered through the use of an articulating or
steerable needle or catheter.
37. The method defined in claim 24, wherein said composition is
directionally delivered through the use of an articulating or
steerable needle or catheter.
38. The method defined in claim 26, wherein a hydrogel material is
injected during the second stage into the central portion of the
repaired intervertebral disc.
Description
RELATED APPLICATIONS
[0001] This application is related to U.S. Provisional Patent
Application Ser. No. 60/738,857, filed Nov. 22, 2005, entitled
METHOD AND COMPOSITION FOR REPAIR AND RECONSTRUCTION OF
INTERVERTEBRAL DISCS AND OTHER RECONSTRUCTIVE SURGERY.
TECHNICAL FIELD
[0002] The present invention relates to a method of injecting a
polymer to treat disordered, insufficient, or injured structures in
a living creature, in particular, a human being. This invention
also relates to a composition suitable for use in such a method,
its preparation and use.
BACKGROUND ART
[0003] Many structures in the human body rely upon the flexibility
or elasticity of the tissue to exhibit the preferred properties or
to perform a desired task. The resilience of the tissue often
provides a means for better load distribution and shock-absorbing
characteristics. The elasticity may function to create a more
natural appearance or more desirable tactile property. Specific
examples of these types of structures include the intervertebral
discs, or the connective and soft tissue beneath the skin, often
associated with providing shape and resilience for the external,
visible parts of the body (i.e., maxillofacial).
[0004] Intervertebral Disc
[0005] The spinal column is composed of 24 vertebrae, which are
stacked on top of each other. The individual bony vertebral bodies
are separated by spinal discs; these soft structures serve several
functions: maintaining the proper spacing and alignment between the
vertebrae, absorbing and distributing loads on the vertebrae. The
intervertebral disc has a strong fibrous outer ring called the
annulus and a softer, gelatinous center called the nucleus
pulposus. The annulus surrounds and contains the nucleus and serves
as a strong ligament that connects the adjacent vertebrae. The
nucleus pulposus provides a shock absorbing mechanism for the
spine. The disc also aids in maintaining the appropriate disc
height to prevent nerve root impingement by adjacent bony spinal
structures.
[0006] As the body ages, the disc loses much of its natural
cushioning properties through the loss of fluids and elasticity.
The annulus may develop small cracks and tears, which can be
painful. Annular tears may weaken the fibrous structure to the
point that the nucleus pulposus is no longer sufficiently contained
and bulges out, or herniates, into the spinal canal or other
structures. This pressure on the spinal cord or nerve roots from
the herniation can cause severe pain and can eventually lead to
impairment of bodily function or paralysis. A herniated disc can
also be caused by placing forces on the spine during standard daily
activities--moving, lifting, sneezing, or by traumatic events.
[0007] The disc height and resilience can be significantly reduced
by the loss or dehydration of nucleus material. The loss of the
"shock-absorbing" ability of the intervertebral discs can increase
the peak loads seen by the adjacent vertebral bodies. In addition,
the aging population often exhibits osteoporosis which can weaken
the vertebral body, increasing the risk for potential vertebral
compression fractures.
[0008] Current treatments for the aging intervertebral disc,
annular tears, and disc herniation include removal of herniated
material through mechanical, laser, or chemical means, insertion of
pre-formed nucleus replacement devices, repair of the annulus by
suturing or changing the structure of the fibers. The disc may be
completely removed and replaced with an articulating prosthesis or
a stationary spinal spacer to fuse the adjacent vertebrae. All of
the options have the same primary goal, which is pain relief at the
affected level, allowing the patient to regain mobility. However,
these treatments affect the natural mechanics of the disc by
changing the properties of the annulus or nucleus, or by completely
replacing the structure(s).
[0009] What is proposed is a therapy which would allow the
clinician to inject a flowable substance which will polymerize in
situ to mimic many of the desired characteristics of the affected
structure. The polymer could be tailored to produce a tougher
material to fill or repair tears or weaknesses in the annulus, and
a softer, more resilient material would be applied to augment or
replace the nucleus pulposus.
Plastic Surgery
[0010] Plastic surgery applications include the filling of voids in
soft tissue or bone that may have occurred due to tumor or cyst
removal, trauma, or deformity correction. The application of the
material would provide underlying support and structure for the
affected areas, and the characteristics of the implant could be
tailored for functional or cosmetic purposes. The durometer of the
polymer can be chosen to better match or augment the tissue that is
being filled, replaced or reconstructed.
[0011] It may also be desirable to select a compliant or flexible
material for void filling or defect repair in bony structures which
are adjacent to soft tissue structures that may be subject to
swelling or edema. The flexibility of the implant could allow a
pressure release or reduction mechanism during the healing and
swelling period. An example would be as a bur hole cover in the
skull. In addition, the compliant, rubber-like nature of this
implant will also allow more accessibility to the underlying tissue
for biopsy, aspiration of fluids, etc.
SUMMARY OF THE INVENTION
[0012] By employing the present invention, all of the difficulties
and drawbacks found in the prior art have been eliminated and a
highly effective method for treating diseased, injured, or
disordered structures, particularly intervertebral discs, in living
creatures is attained. In addition, the present invention also
achieves a unique composition particularly formulated and suitable
for use in the method of the present invention.
[0013] The method of the present invention comprises the injection
of an elastomeric filler into the structure to be treated via a
percutaneous route, usually under X-Ray guidance, such as lateral
projection fluoroscopy. The material is injected as a paste or
semi-liquid from a suitable gun or injection system via a needle,
that has been passed into body to apply the material to the
affected area. The elastomeric filler, once injected, will
polymerize in situ. The resulting material provides reinforcement
to or replacement of tissue or anatomical structures that are
deficient due to the aging process, tumor removal or other surgical
intervention, trauma. In addition to the reinforcing, strengthening
and shock-absorbing properties, it is desirable that the starting
filler composition is of a viscosity that allows it to flow into
the voids or spaces as required.
[0014] Therefore, it is a principal object of the present invention
to provide filler material and a method for using the filler
material into an intervertebral disc, the substrate beneath the
cartilage in articulating joints, the voids in bony or
cartilaginous structures created or treated during plastic or
neurosurgical procedures, or other similar applications, which is
easily prepared and delivered to the affected area while also
providing the desired filling, reinforcing, strengthening and
shock-absorbing properties.
[0015] Another object of the present invention is to provide filler
material and a method for using the filler material in the affected
areas having the characteristic features described above which is
inherently flexible and viscous to provide flowability throughout
the structures as required both during its application and after
curing, thereby achieving self-regulating control realized from the
fluid properties of the injected liquid and the elastomeric
characteristics of the polymerized material.
[0016] Another object of the present invention is to provide filler
material and a method for using the filler material in the body
having the characteristic features described above which is capable
of being prepared to exhibit varying levels of hardness or
stiffness after curing, thereby allowing the selection and
formulation of the filler material with appropriate mechanical
properties specifically suited for each application.
[0017] Another object of the present invention is to provide filler
material and a method for using the filler material in the body
having the characteristic features described above which is capable
of being prepared with additives that remain active for a length of
time after curing, thereby allowing localized therapeutic treatment
of the affected area or anatomic structure.
[0018] Another object of the present invention is to provide a
method for application of the filler material in the body in a
controlled and directed manner that results in the placement of the
material in targeted areas and having a specific geometry that is
preferred for the treatment modality.
[0019] Other and more specific objects will in part be obvious and
will in part appear hereinafter.
THE DRAWINGS
[0020] For a fuller understanding of the nature and objects of the
invention, reference should be had to the following detailed
description taken in connection with the accompanying drawings, in
which:
[0021] FIG. 1 is a front perspective view, partially broken away,
depicting the anatomy of a spinal column with one associated
intervertebral disc;
[0022] FIGS. 2-4 are rear perspective views, partially broken away,
depicting various stages in the process of the process of the
present invention.
DETAILED DISCLOSURE
[0023] By referring to FIGS. 1-4, along with the following detailed
disclosure, one of the principal treatment methods of the present
invention can best be understood. In this regard, as detailed
above, the present invention can be implemented in many areas of a
human body. However, one principal application of the present
invention is in the repair of intervertebral discs. In addition,
the unique formulation of the material employed in the method of
the present invention is also fully disclosed. However, alterations
or variations in both the method and the formulation of the
material can be made without departing from the scope of the
present invention. Consequently, it is to be understood that the
following detailed discussion and the drawings are provided for
exemplary purposes only and are not intended as a limitation of the
present invention.
[0024] In FIG. 1, a portion of a conventional spinal column 20 is
depicted, with vertebral bodies 21 and 22 shown incorporating
intervertebral disc 23 interposed therebetween. Each vertebral body
21 and 22 incorporates bony structure 25 extending therefrom along
with spinal cord 26 axially extending along the entire length of
spinal column 20, in nested protective engagement with bony
structures 25.
[0025] As detailed above, each intervertebral disc 23 maintains the
proper spacing and alignment between vertebral bodies 21 and 22,
while also absorbing and distributing loads imposed upon the
vertebrae. Due to aging, injury, and excessive loads,
intervertebral disc 23 often incurs a wide variety of injuries or
physical degradation loses, causing the disc to lose much of its
natural cushioning properties. In addition, cracks or tears in the
disc structure weaken the fibrous structure forming the disc, often
causing the disc to deform, bulge, or herniate into the spinal
canal or other structures. These various maladies cause severe
pain, as well as leading to an impairment of various bodily
functions.
[0026] By employing the present invention, any damaged or impaired
intervertebral disc 23 is capable of being repaired in a direct,
easily implemented process. As detailed herein, a needle or cannula
is inserted into the damaged or impaired vertebral disc 23 and a
uniquely formulated, curable, filler composition is injected into
the interior of the intervertebral disc. In the preferred
embodiment, the curable filler material comprises an elastic form
stable material which is allowed to cure or polymerize in situ,
effectively reforming the damaged intervertebral disc 23 and curing
the damages or impairments originally present in disc 23.
[0027] By referring to FIGS. 2-4, along with the following detailed
discussion, the method of the present invention can best be
understood. As shown therein, intervertebral disc 23 comprises a
strong fibrous outer ring or annulus 30 and a softer, gelatinous
center or nucleus pulposus 31. Annulus 30 surrounds and contains
nucleus pulposus 31 and serves as a strong ligament that connect
the adjacent vertebrae. In addition, nucleus pulposus 31 provides a
shock absorbing mechanism for the spine, with disc 23 maintaining
the appropriate height to prevent nerve root impingement by
adjacent bony spinal structures 25.
[0028] As discussed above, due to the aging process and/or injury,
nucleus pulposus 31 often loses fluids and elasticity, thereby
losing much of its natural cushioning properties. Furthermore,
annulus 30 often develops cracks or tears, which weaken the fibrous
structure thereof to a sufficient extent that nucleus pulposus 31
is no longer sufficiently contained within annulus 30.
[0029] These problems frequently occur, resulting in various
physical difficulties, including severe pain, impairment of bodily
functions, impairment of daily activities and/or paralysis.
However, by employing the present invention, intervertebral disc 23
can be repaired and the physical difficulties eliminated or
substantially reduced.
[0030] In accordance with the present invention, a flowable,
curable filler composition comprising an elastic form stable
material is injected directly into nucleus pulposus 31 and allowed
to cure in situ. Once the elastic form stable material has
polymerized, the material mimics the physical characteristics
inherently present in nucleus pulposus 31.
[0031] In this way, all of the physical difficulties or impairments
suffered by the individual are virtually eliminated or
substantially reduced. In addition, by forming the flowable,
curable filler composition of the present invention to impart a
tougher material to disc 23 when cured, tears or weaknesses in
annulus 30 of disc 23 are able to be repaired.
[0032] As shown in FIG. 2, in employing the method of the present
invention, needle or cannula 35 is inserted into the individual to
be treated and positioned directly adjacent annulus 30 of disc 23
to be repaired. Once in the proper position, needle/cannula 35 is
advanced through annulus 30 with the tip thereof entering nucleus
pulposus 31, as depicted in FIG. 3. Thereafter, as shown in FIG. 4,
curable filler composition 38 is advanced through needle/cannula 35
into nucleus pulposus 31, filling or augmenting the area defined by
nucleus pulposus 31 in order to provide the improved and enhanced
properties thereto. Once the desired quantity of filler material 38
has been added into nucleus pulposus 31, needle/cannula 35 is
withdrawn and filler material 38 is allowed to cure in order to
provide the desired enhanced beneficial results to disc 23.
[0033] In accordance with the present invention, it has been found
that the preferred curable filler composition comprises an elastic
form stable material. Preferably, this material comprises a
silicone elastomer, with poly (dimethyl siloxane) being preferred.
In addition, in the preferred formulation, the composition also
incorporates a cross-linking agent and a diluent.
[0034] One composition of the curable filler material of the
present invention which has been found to be extremely successful
comprises between about 60% and 85% by weight based upon the weight
of the entire composition of poly (dimethyl siloxane), between
about 2% and 5% by weight based upon the weight of the entire
composition of a cross-linking agent, and between about 10% and 20%
by weight based upon the weight of the entire composition of a
diluent. In addition, if desired, a radiopaque material may be
incorporated into the composition in order to enable the delivery
of the material into disc 23 to be monitored by using suitable
equipment, such as x-rays.
[0035] In this regard, it has been found that between about 100%
and 20% by weight based upon the weight of the entire composition
of the radiopaque material is preferably employed. In addition, the
radiopaque material preferably comprises one selected from the
group consisting of silver powder, barium sulfate, bismuth
trioxide, zirconium dioxide, tantalum or titanium powders or
fibers, calcium sulfate, calcium phosphate, hydroxyapetite,
tri-calcium phosphate, and other medically appropriate opacifier
agents.
[0036] One preferred formulation of the "cure-in-place" silicone
elastomer of the present invention comprises two highly viscous
liquid components, namely reinforced dimethyl methylvinyl siloxanes
and reinforced dimethyl methylhydrogen siloxanes, supplied in equal
parts (1:1 ratio). In addition, this preferred composition is
preferably supplied in a pre-filled, two-part mixing and dispensing
cartridge/syringe system wherein the two viscous liquid components
are maintained separately until the time of use. When desired, the
components are thoroughly intermixed with each other in the desired
uniform ratio to achieve the desired uniform consistency.
[0037] Once the mixing process has been completed, the resulting
silicone elastomer is immediately injected into the desired site
wherein the material polymerizes in situ in approximately 3 to 15
minutes. Once cured, the silicone elastomer results in a tough,
rubbery consistency which has low toxicity and presents a low risk
of unfavorable biological reactions. In addition, the preferred
formulation preferably incorporates a radio-opaque material in
order to enable the delivery of the material to be monitored with
standard fluoroscopy.
[0038] In accordance with the present invention, it has been found
at the following compositions represents the preferred formulations
for the two component system of this invention:
[0039] Component A:
[0040] Vinyldimethyl terminated dimethyl
polysiloxane/trimethylsiloxy terminated polydimethyl siloxane,
64%
[0041] Silica, amorphous, 21%
[0042] Barium Sulfate powder, USP, 15%
[0043] Pt Catalyst>0.001%
[0044] Component B:
[0045] Vinyldimethyl terminated dimethyl
polysiloxane/trimethylsiloxy terminated polydimethyl siloxane,
63%
[0046] Silica, amorphous, 21%
[0047] Barium Sulfate powder, USP, 15%
[0048] Trimethyl methyl-hydro dimethyl siloxane (crosslinker),
1%
By employing the compositions detailed above, all of the desired
goals and objectives of the present invention are realized.
[0049] It has also been found that the curable filler material
employed in the method of the present invention preferably
possesses a durometer in the cured state which ranges between about
10 A and 90 A. In addition, it has also been found that the curable
filler material can be delivered to disc 23 in two stages, with the
first stage being employed to fill cracks or tears in annulus 30,
while the second stage is employed to repair nucleus pulposus 31.
In this regard, the second stage material is delivered to disc 23
after the first stage material has cured. By employing this
process, assurance is provided that the material supplied during
the second stage is completely retained in disc 23, since any
damage or maladies in annulus 23 are fully repaired prior to the
delivery of the material for the second stage.
[0050] If desired, it has been found that the delivery of the
curable filler material to disc 23 in two stages can be achieved in
a manner which closely resembles or mimics the normal, anatomical
construction. In this regard, the first stage of the repair of
annulus 30 is achieved by employing filler material resulting in a
durometer in the cured state which ranges between about 30 A and 90
A. In addition, in the second stage, which is employed to repair
nucleus pulposus 31, the filler material employed comprises a
durometer in the cured state which ranges between about 10 A and 50
A. By employing this dual durometer or differential material
construction, the natural or normal anatomical configuration is
realized, with a softer, more flexible, and more compressible
material forming nucleus pulposus 31 while being peripherally
surrounded by a stronger material forming annulus 30.
[0051] It has also been found that the present invention can be
implemented by employing a hydrogel as the material for forming
nucleus pulposus 31. In this regard, the silicone elastomer
detailed above is employed for forming the first stage or repairing
annulus 30 in the manner detailed above. Once cured, the second
stage of the repair is implemented by injecting a hydrogel into
annulus 30 forming nucleus pulposus 31. In this way, the desired
disc repair is achieved in a manner which achieves all of the
desired goals and objectives.
[0052] It has also been found that the method of the present
invention can be employed in combination with a disc oblation
procedure. In this regard, a void is created within intervertebral
disc 23 and, once established, the curable filling material of the
present invention is supplied thereto. Furthermore, it has also
been found that the process of the present invention can be
employed in combination with a balloon kyphoplasty procedure or
similar deployment of an expandable device or with a steerable
biopsy needle or instrument. In this procedure, an expandable
balloon or similar device is inserted into disc 23 as a replacement
or reinforcement for annulus 30. Once in position, the curable
filler material of the present invention is delivered into the
balloon or expandable device for providing the filler material
thereto, or to inject the material and expand a balloon to compress
the material outward toward the annulus forming a reinforced
surface. Alternatively, a steerable instrument, such as an
articulating or flexible needle or catheter may be used to coat the
interior surface of the annulus thus reinforcing it.
[0053] Although the foregoing detailed disclosure has focused on
the use of the present invention in connection with the repair or
reconstruction of a disordered intervertebral disc, the present
invention has equal applicability and efficacy in other surgical
areas, as discussed above. In this regard, plastic surgery
represents another specific area where the method and material
composition and formulations of the present invention is equally
applicable. Consequently, all of the foregoing detailed disclosure
is hereby repeated and reiterated herein, with complete
applicability to these other areas where the same overall
procedures and material formulations can be employed.
[0054] It will thus be seen that the object set forth above, among
those made apparent from the preceding description, are efficiently
attained and, since certain changes may be made in carrying out the
above method and in the composition set forth without departing
from the scope of the invention, it is intended that all matter
contained in the above description or shown in the accompanying
drawings shall be interpreted as illustrative and not in a limiting
sense.
[0055] It is also to be understood that the following claims are
intend to cover all of the generic and specific features of the
invention herein described, and all statements of the scope of the
invention which, as a matter of language, might be said to fall
therebetween.
[0056] Particularly, it is to be understood that in said claims,
ingredients or compounds recited in the singular are intended to
include compatible mixtures of such ingredients wherever the sense
permits.
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